Medical Device Manufacturer · US , Walker , MI

S & W Medico Teknik - FDA 510(k) Cleared Devices

46 submissions · 46 cleared · Since 1984

46

Total

46

Cleared

0

Denied

FDA 510(k) Regulatory Record - S & W Medico Teknik Anesthesiology ✕

15 devices

1-12 of 15

Cleared Nov 29, 1995

9267 SPO2 ATHENA MODULE

Anesthesiology · 639d

Cleared May 03, 1994

TCPO2 9260 MODULE - SYSTEM ATHENA

Anesthesiology · 1030d

Cleared Feb 23, 1993

9293/1 INTERFACE MODULE

Anesthesiology · 225d

Cleared Dec 17, 1992

VENTILATOR INTERFACE 9291/4

Anesthesiology · 213d

Cleared May 05, 1992

SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA

Anesthesiology · 392d

Cleared Oct 31, 1991

SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION

Anesthesiology · 223d

Cleared Aug 02, 1991

CALIBRATION KIT

Anesthesiology · 144d

Cleared Sep 27, 1990

MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA

Anesthesiology · 113d

Cleared Aug 14, 1990

TYPE 9293 INTERFACE PULSEOX

Anesthesiology · 257d

Cleared Jul 17, 1990

TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)

Anesthesiology · 655d

Cleared Feb 28, 1990

TYPE 9290 INTERFACE RESPIRATOR

Anesthesiology · 90d

Cleared Feb 28, 1990

TYPE 9291 INTERFACE RESPIRATOR

Anesthesiology · 90d